In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, [2017-2508] (February 6, 2019), the Federal Circuit affirmed the district court’s holding that claims 6–9 of U.S. Patent 7,267,820 (the “’820 patent”) are invalid under
35 U.S.C. § 101 and dismissing Athena’s complaint under Rule 12(b)(6).
The inventors discovered the association between MuSK autoantibodies
and Myasthenia gravis, and in the ’820 patent disclosed and claimed methods of diagnosing neurological isorders such as MG by detecting autoantibodies that bind to a MuSK epitope.
The Federal Circuit agreed that the claims were directed to a natural law, specifically, the correlation between the presence of naturally-occurring
MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG. The Federal Circuit said “This correlation
exists in nature apart from any human action. There can
thus be no dispute that it is an ineligible natural law.”
The Federal Circuit concluded that the claims were directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law. This finding was bolstered by the truthful but unfortunate statements in the specification that “[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art.”
The Federal Circuit said: “The claims here are directed to a natural law because they recite only the natural law together with standard techniques
for observing it. That the routine steps are set forth with some specificity is not enough to change that conclusion.”
Finally, the Federal Circuit rejected Athena’s argument that the claims were patentable because they required labeling MuSK with a manmade
substance, finding that the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.
At step II of the aptly named Mayo test, the Federal Circuit found that the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only required standard
techniques to be applied in a standard way. This was bolstered by the specification’s description of the steps as “conventional techniques.” The Federal Circuit refused to hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept.